Ankylosing SpondylitisNCT06287983
Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity
A study testing Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic) and The Sample Spondylitis Exercise Program in people with Ankylosing Spondylitis, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aimed to evaluate the effect of Anti- tumor necrosis factor (TNF) treatment on pulmonary functions in patients with AS and to evaluate the pulmonary functions and exercise performance of patients by adding inspiratory muscle training to spinal mobility exercises in patients with AS using Anti-TNF. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic) and The Sample Spondylitis Exercise Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with ankylosing spondylitis according to the Modified New York Criteria
- Patients with BASDAI score <4.1 who received Anti-TNF therapy for at least 6 months
- Patients whose maximum inspiratory pressure value is <80% in the Pulmonary Function Test
- Patients who had a cardiac examination within the last year and no cardiac pathology was detected.
Who cannot join
- The patient has a serious mental disorder
- Presence of neurological and pulmonary disease that would prevent the patient from using the PFT device
- Presence of uncontrolled hypertension
- Presence of uncontrolled diabetes
- Presence of uncontrolled cardiac arrhythmia
- Uncontrolled heart failure
Show all 12Show fewer
- High-risk unstable angina and all acute cardiac diseases (acute myocardial infarction, acute endocarditis, myocarditis or pericarditis)
- Symptomatic severe aortic stenosis
- Acute pulmonary embolism or pulmonary infarction
- Severe pulmonary hypertension
- Presence of systemic infection or malignancy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital
Kayseri, 38080
Havva Talay Çalış, Prof, +90352 315 77 00 ext. 61244, htalaycalis@yahoo.com
Esra Yaprak Tas, MD, +905062007571, yaprak8100@gmail.com
About this study
Official title: Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity in Patients With Ankylosing Spondylitis Receiving Anti-TNF Therapy: Randomized Controlled Study.
In this study, we aimed to evaluate the effect of Anti- tumor necrosis factor (TNF) treatment on pulmonary functions in patients with AS and to evaluate the pulmonary functions and exercise performance of patients by adding inspiratory muscle training to spinal mobility exercises in patients with AS using Anti-TNF. We also aimed to investigate the relationship between these parameters and disease activity, spinal mobility and quality of life.
Read the detailed description
Patients diagnosed with AS who applied to outpatient clinic, received anti- tumor necrosis factor (TNF) treatment for at least 6 months and have been evaluated will be included in the study.
Patients who agree to participate in the study will be asked to sign a consent form. At the beginning, all patients' name-surname, age, height, body weight, body mass index, smoking-alcohol use, profession, marital status, education, duration of ankylosing spondylitis disease, history of corticosteroid use, presence of systemic and extra-articular involvement, medications used and additional diseases will be questioned and recorded in their files.
It was planned to include 30 male and 14 female patients in the study by calculating the female/male ratio of patients diagnosed with As who applied to hospital in the last year and in line with the literature. A total of 44 patients will be randomly randomized into 2 groups using the sealed envelope randomization method. The exercise program will be applied to both groups, 3 sessions a week for 60 minutes for 6 weeks.
The Sample Spondylitis Exercise Program recommended by the Spondylitis Association of America will be translated into Turkish and each exercise will be applied in 3*10 sets.
Inspiratory muscle training will also be added to the intervention group.
Inspiratory muscle training will be started at an intensity of 50% of the patient's measured PIMAX value and will be increased by 2 cm/H20 per day according to patient tolerance, and will be applied for a total of 6 weeks / 5 days per week / 3 sessions per day / 10 breaths per session.
Patients included in the study were evaluated with BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), BASFI(Bath Ankylosing Spondylitis Functional Index), ASQoL(The Ankylosing Spondylitis Quality of Life), Modified Borg Scale, measurement of dyspnea at maximum exercise with Visual Analog Scale (VAS), 6-minute walk test, chest expansion measurement and respiratory function test (spirometry) at 0, 6, 12 and 24 weeks will be evaluated.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic), The Sample Spondylitis Exercise Program
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic)Device
Inspiratory muscle training will be started at an intensity of 50% of the patient's measured PIMAX value and will be increased by 2 cm/H20 per day according to patient tolerance, and will be applied for a total of 6 weeks / 5 days per week / 3 sessions per day / 10 breaths per session.
The Sample Spondylitis Exercise ProgramOther
The Sample Spondylitis Exercise Program recommended by the Spondylitis Association of America will be translated into Turkish and each exercise will be applied in 3*10 sets. The exercise program will be applied to both groups, 3 sessions a week for 60 minutes for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| EXERCISE GROUP | Experimental | The Sample Spondylitis Exercise Program Receives: Other: The Sample Spondylitis Exercise Program |
| EXERCISE+ Inspiratory muscle trainer (IMT) GROUP | Active comparator | The Sample Spondylitis Exercise Program Inspiratory muscle training will also be added to the intervention group. Receives: Device: Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic); Other: The Sample Spondylitis Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory function test (Spirometry)
Spirometry is the most commonly used respiratory function test (PFT). It is a physiological test based on measuring the flow or volume changes that occur during breathing as a derivative of time. The standard maneuver used during spirometry is also called the forced expiratory maneuver; It consists of rapid and deep inspiration followed by maximal expiration at the level of total lung volume. The spirometry test to be evaluated must comply with the previously defined spirometry test performance standards, acceptability and repeatability criteria. In the study, the most frequently measured spirometric parameters with forced expiration maneuver were; vital capacity (VC), forced vital capacity (FVC), forced expiratory volume (FEV), maximum inspiratory pressure (PImax) and maximum expiratory pressure (Pemax) to evaluate respiratory muscle strength will be checked.
Measured: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Secondary outcomes (7)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI):
It evaluates disease-specific symptoms such as fatigue, spinal and peripheral joint pain, swelling and morning stiffness and is interpreted on a score ranging from 0-10. An increase in the score indicates an increase in disease activity. It is a reliable and sensitive index developed to evaluate disease activity and progression.
Measured: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Bath Ankylosing Spondylitis Functional Index (BASFI)
It is a fast and easy-to-apply, sensitive and reliable index developed to determine and monitor the functional status of patients with AS. It consists of 10 questions that evaluate patients' abilities to bend, reach, stand, change positions, climb stairs, and cope with activities of daily living. For each question, the final score is obtained by dividing the total score by 10 using VAS in the range of 0-10 cm.
Measured: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)
ASQoL is the most widely used, valid and reliable questionnaire to evaluate the quality of life in AS. In this survey, which consists of eighteen questions, patients are asked to answer yes or no to each question. '0' points are taken for a no answer and '1' point is taken for a yes answer. Total score varies between 0-18. High scores indicate serious impairments in quality of life.
Measured: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Modified Borg Scale
It is a scale frequently used to evaluate the severity of exertion dyspnea and resting dyspnea severity. It consists of ten items that describe the severity of dyspnea according to its degree. Defining the severity of dyspnea in the Modified Borg Scale makes it easier for patients to apply.
Measured: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Measurement of dyspnea at maximum exercise with the Visual Analog Scale (VAS)
Visual Analog Scale (VAS) is a scale applied by marking with a pencil on a horizontal or vertical line of one hundred millimeters. There is no dyspnea at the 0 mm point of this line, and the most severe dyspnea is at the 100 mm point. The patient marks the severity of the current respiratory distress on the scale using these two degrees as criteria. Scoring is done by measuring the marked point with the help of a tape measure. Most of the studies conducted to date indicate that VAS is a reliable scale that can be used to evaluate the severity of dyspnea, and that it is even sensitive to minute changes in the severity of dyspnea.
Measured: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
6-minute walk test (6MWT)
It is a frequently used test in cardiopulmonary rehabilitation to monitor exercise capacity and treatment effectiveness. The patient should rest by sitting in a chair for 15 minutes before the test and wear appropriate shoes and comfortable clothing. Calculate the distance walked by the patient at their own walking pace in 6 minutes, preferably in a 30-meter long corridor. If the patient's O2 saturation (sO2) is <88%, the test should be performed with O2 support.
Measured: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Chest expansion measurement
Chest expansion is measured at the fourth intercostal space. The patient is asked to exhale all the air in his lungs and then take deep inspiration. As a result of deep inspiration, the expansion around the chest is recorded in centimeters.
Measured: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Jun 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A total of 44 patients were randomly divided into 2 groups using the sealed envelope randomization method. The exercise program will be applied to both groups 3 sessions a week for 60 minutes for 6 weeks. Inspiratory muscle training will also be added to the intervention group. Patients included in the study; At weeks 0, 6, 12 and 24, BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), BASFI (Bath Ankylosing Spondylitis Functional Index), ASQoL (The Ankylosing Spondylitis Quality of Life), Modified Borg Scale, Visual Analog scale (VAS) and maximum Dyspnea measurement during exercise, 6-minute walk test, chest expansion measurement and respiratory function test (spirometry) will be evaluated.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Havva Talay Çalış, Kayseri City Hospital
- Investigators
- Serap Tomruk Sütbeyaz, Prof, Study director, Saglik Bilimleri UniversitesiEsra Yaprak tas, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287983
- Sponsor's protocol ID
- KayseriCHIMT001
- Status last verified
- Mar 2024
- First submitted
- 24 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity in Patients With Ankylosing Spondylitis Receiving Anti-TNF Therapy: Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06287983
- Acronym / sponsor ID
- KayseriCHIMT001
- Conditions
- Ankylosing Spondylitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, we aimed to evaluate the effect of Anti- tumor necrosis factor (TNF) treatment on pulmonary functions in patients with AS and to evaluate the pulmonary functions and exercise performance of patients by adding inspiratory muscle training to spinal mobility exercises in patients with AS using Anti-TNF. We also aimed to investigate the relationship between these parameters and disease activity, spinal mobility and quality of life.
Detailed description
Patients diagnosed with AS who applied to outpatient clinic, received anti- tumor necrosis factor (TNF) treatment for at least 6 months and have been evaluated will be included in the study.
Patients who agree to participate in the study will be asked to sign a consent form. At the beginning, all patients' name-surname, age, height, body weight, body mass index, smoking-alcohol use, profession, marital status, education, duration of ankylosing spondylitis disease, history of corticosteroid use, presence of systemic and extra-articular involvement, medications used and additional diseases will be questioned and recorded in their files.
It was planned to include 30 male and 14 female patients in the study by calculating the female/male ratio of patients diagnosed with As who applied to hospital in the last year and in line with the literature. A total of 44 patients will be randomly randomized into 2 groups using the sealed envelope randomization method. The exercise program will be applied to both groups, 3 sessions a week for 60 minutes for 6 weeks.
The Sample Spondylitis Exercise Program recommended by the Spondylitis Association of America will be translated into Turkish and each exercise will be applied in 3*10 sets.
Inspiratory muscle training will also be added to the intervention group.
Inspiratory muscle training will be started at an intensity of 50% of the patient's measured PIMAX value and will be increased by 2 cm/H20 per day according to patient tolerance, and will be applied for a total of 6 weeks / 5 days per week / 3 sessions per day / 10 breaths per session.
Patients included in the study were evaluated with BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), BASFI(Bath Ankylosing Spondylitis Functional Index), ASQoL(The Ankylosing Spondylitis Quality of Life), Modified Borg Scale, measurement of dyspnea at maximum exercise with Visual Analog Scale (VAS), 6-minute walk test, chest expansion measurement and respiratory function test (spirometry) at 0, 6, 12 and 24 weeks will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A total of 44 patients were randomly divided into 2 groups using the sealed envelope randomization method. The exercise program will be applied to both groups 3 sessions a week for 60 minutes for 6 weeks. Inspiratory muscle training will also be added to the intervention group. Patients included in the study; At weeks 0, 6, 12 and 24, BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), BASFI (Bath Ankylosing Spondylitis Functional Index), ASQoL (The Ankylosing Spondylitis Quality of Life), Modified Borg Scale, Visual Analog scale (VAS) and maximum Dyspnea measurement during exercise, 6-minute walk test, chest expansion measurement and respiratory function test (spirometry) will be evaluated.
| Arm | Type | Receives |
|---|---|---|
| EXERCISE GROUP | Experimental | Other: The Sample Spondylitis Exercise ProgramThe Sample Spondylitis Exercise Program |
| EXERCISE+ Inspiratory muscle trainer (IMT) GROUP | Active comparator | Device: Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic), Other: The Sample Spondylitis Exercise ProgramThe Sample Spondylitis Exercise Program Inspiratory muscle training will also be added to the intervention group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with ankylosing spondylitis according to the Modified New York Criteria
- Patients with BASDAI score <4.1 who received Anti-TNF therapy for at least 6 months
- Patients whose maximum inspiratory pressure value is <80% in the Pulmonary Function Test
- Patients who had a cardiac examination within the last year and no cardiac pathology was detected.
Key exclusion criteria (12 listed)
- The patient has a serious mental disorder
- Presence of neurological and pulmonary disease that would prevent the patient from using the PFT device
- Presence of uncontrolled hypertension
- Presence of uncontrolled diabetes
- Presence of uncontrolled cardiac arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic)Inspiratory muscle training will be started at an intensity of 50% of the patient's measured PIMAX value and will be increased by 2 cm/H20 per day according to patient tolerance, and will be applied for a total of 6 weeks / 5 days per week / 3 sessions per day / 10 breaths per session. | Device | EXERCISE+ Inspiratory muscle trainer (IMT) GROUP |
| The Sample Spondylitis Exercise ProgramThe Sample Spondylitis Exercise Program recommended by the Spondylitis Association of America will be translated into Turkish and each exercise will be applied in 3*10 sets. The exercise program will be applied to both groups, 3 sessions a week for 60 minutes for 6 weeks. | Other | EXERCISE GROUP, EXERCISE+ Inspiratory muscle trainer (IMT) GROUP |
Primary outcome
Respiratory function test (Spirometry)
Time frame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Spirometry is the most commonly used respiratory function test (PFT). It is a physiological test based on measuring the flow or volume changes that occur during breathing as a derivative of time. The standard maneuver used during spirometry is also called the forced expiratory maneuver; It consists of rapid and deep inspiration followed by maximal expiration at the level of total lung volume. The spirometry test to be evaluated must comply with the previously defined spirometry test performance standards, acceptability and repeatability criteria. In the study, the most frequently measured spirometric parameters with forced expiration maneuver were; vital capacity (VC), forced vital capacity (FVC), forced expiratory volume (FEV), maximum inspiratory pressure (PImax) and maximum expiratory pressure (Pemax) to evaluate respiratory muscle strength will be checked.
7 secondary outcomes
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI):
Time frame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)
Time frame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Modified Borg Scale
Time frame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Measurement of dyspnea at maximum exercise with the Visual Analog Scale (VAS)
Time frame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
6-minute walk test (6MWT)
Time frame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Chest expansion measurement
Time frame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serap Tomruk Sütbeyaz, Prof study director
Saglik Bilimleri Universitesi
Esra Yaprak tas principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic) and The Sample Spondylitis Exercise Program in people with Ankylosing Spondylitis, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Havva Talay Calıs, Prof (+90532 687 45 41, htalaycalis@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory function test (Spirometry) (time frame: before treatment (day 0), after treatment (week 6), after treatment (week 12), after treatment (week 24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.